Quality Manager- Medical Devices- Buffalo, NY

My client is seeking the Quality Manager will lead a dynamic team in a growing medical technology facility, overseeing all quality systems and ensuring compliance with FDA and ISO-13485 standards. This role combines strategic leadership and hands-on management to drive continuous improvement, support regulatory readiness, and foster a culture of operational excellence at the Buffalo, NY facility.

Client Details

My client is a growing manufacturer in the medical technology industry, focused on delivering innovative, life-enhancing solutions. With a culture centered on integrity, teamwork, and continuous improvement, the company empowers its employees to take ownership and drive meaningful impact.

The facility operates across multiple buildings and plays a key role in the organization's broader growth strategy. Known for its strong focus on quality and regulatory compliance, the company values cross-functional collaboration and lean principles to ensure efficiency and high product standards. This is an ideal setting for engineers who are driven by purpose and enjoy leading in a dynamic, technical environment.

Description

The Quality Manager will:

• Serve as the site Quality leader and Management Representative, ensuring compliance with FDA, ISO-13485, and other applicable regulations.
• Lead and develop a quality team of 20+ associates, including 9-10 direct reports.
• Oversee all aspects of the quality management system, including document control, CAPA, training, audits, and product release.
• Act as primary liaison with regulatory bodies, customers, and suppliers on quality-related matters.
• Drive continuous improvement initiatives using Lean Six Sigma and root cause analysis methodologies.
• Ensure readiness for and successful execution of internal and external audits.
• Collaborate with plant leadership to define and achieve key quality performance metrics.
• Direct the implementation and monitoring of corrective and preventive actions.
• Guide the development and maintenance of complaint handling and discrepancy resolution processes.
• Review and approve quality system documentation and changes.
• Provide strategic input to align quality systems with business growth and operational goals.
• Support training and career development across the quality function to build team capabilities.

Profile

The successful Quality Manager Candidate will have:

• 5+ years of quality leadership experience in a regulated industry (medical device, aerospace, or automotive preferred).
• Proven track record managing quality systems in compliance with FDA, ISO-13485, and related standards.
• Bachelor's degree required; advanced degree in engineering, quality, or related field preferred.
• Experience leading regulatory inspections and successful audit outcomes.
• Demonstrated ability to lead and develop high-performing quality teams.
• Strong knowledge of CAPA, internal audits, complaint handling, and document control.
• Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.
• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.
• Effective communicator with strong interpersonal and leadership skills.
• Skilled in cross-functional collaboration and influencing at multiple organizational levels.
• Data-driven decision maker with strong analytical and problem-solving skills.
• Experience in a contract manufacturing environment.

Job Offer

On Offer for the Quality Manager is:

• Competitive base salary and bonus potential up to 12%
• Comprehensive health benefits starting on day one (medical, dental, vision)
• 401k match
• Company-paid life insurance and additional voluntary coverage options
• Support for professional development through training and tuition reimbursement
• Career progression opportunities with a clearly defined advancement path
• Access to wellness resources, including fitness discounts and holistic health support
• Financial planning assistance and employee discount programs
• Family-friendly benefits, including caregiving support and pet insurance options
• Structured onboarding and mentorship for new hires
• Dynamic, growth-oriented work environment with strong leadership support

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